Regulatory Focus™ > News Articles > 11 > Recon: AbbVie Plans New San Francisco R&D Hub; Merrimack to Cut 60% of Staff

Recon: AbbVie Plans New San Francisco R&D Hub; Merrimack to Cut 60% of Staff

Posted 08 November 2018 | By Michael Mezher 

Recon: AbbVie Plans New San Francisco R&D Hub; Merrimack to Cut 60% of Staff

Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.
In Focus: US
  • AbbVie hatches plans for a major new R&D hub close to its partners in Bay Area’s buzzy Oyster Point (Endpoints) (SF Business Times)
  • Meet the New Agenda Setters in the House (WSJ) (NBC)
  • Dem overtures to Trump on drug pricing worry pharma (The Hill) (Fierce) (STAT)
  • 8 burning questions for pharma, as Washington braces for a health policy shakeup (STAT)
  • Sage depression drug to cost between $20K and $35K, if approved (BioPharmaDive)
  • Merrimack axes 60% of staff, mulls sale after clinical flops (Fierce) (Endpoints)
  • Jazz’s Vyxeos rollout hit a wall in Q3. What’s the holdup? (Fierce) (Pharmafile)
  • Harvard Medical School receives record $200 million gift for research — and an incubator (STAT)
  • Behind the patent thicket: tactics AbbVie allegedly used to thwart biosimilar versions of Humira (STAT) (Evaluate)
  • Voyager’s shares sink after execs say FDA has reversed course on an accelerated filing for its gene therapy (Endpoints)
  • Opinion: The FDA Was Wise to Approve a New Opioid (WSJ)
  • Endo targets 2020 for launch of cellulite treatment (Reuters)
  • Superbugs pose a dangerous, $65 billion threat to the US health-care system (CNBC)
  • Genentech sues indicted ex-employees and biosim maker over trade secrets theft (Fierce) (BioCentury)
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In Focus: International
  • Biosimilar drugs promise to slash health-care costs in rich countries (The Economist)
  • AstraZeneca shares surge as new drugs spark hope of growth (Financial Times) (Endpoints) (PMLive)
  • AZ drops midstage cancer drug vistusertib (Fierce)
  • Hikma and Vectura agree to develop generic rival to asthma drug (Financial Times)
  • Pharma Slammed Over European Hospital Drug Shortages (Pink Sheet-$)
  • Six in ten UK hospital pharmacists encounter medicines shortages daily, finds survey (Pharmaceutical Journal)
  • Speedy NICE Support For Eisai's Lenvima In Liver Cancer (SCRIP-$)
  • MedCity moves to foster U.K. advanced therapy collaborations (Fierce)
  • Israel's Intec Pharma eyes revenue from Parkinson's drug in 2019 (Reuters)
  • Uganda is vaccinating for fear of Ebola virus spread (NBC)
  • China Set To Become Global Drug Innovation Center (SCRIP-$)
  • EMA Explains Use Of Extrapolation In Developing Medicines For Children (Pink Sheet-$)
  • AMR superbugs expected to kill 90,000 Britons in the next 30 years (Pharmafile)
  • WHO supports district health facilities in Yemen to respond to basic health needs (WHO)
Pharmaceuticals & Biotechnology
  • Active Ingredient In Marijuana Reduced Alzheimer's-Like Effects In Mice (NPR)
  • Increasing the Participation of Pregnant Women in Clinical Trials (JAMA)
  • Novel antibiotic shows promise in treatment of uncomplicated gonorrhea (NIH)
  • BioMarin eyes 2019 FDA filing for haemophilia A gene therapy (PMLive)
  • Immunotherapy Combinations in Multiple Myeloma — Known Unknowns (NEJM)
  • GSK execs change their tune as AZ, Sanofi heap pressure on respiratory hopeful Nucala (Fierce)
  • Bicycle Therapeutics picks up former Pfizer head as new SVP of Pre-Clinical Development (Pharmafile)
  • The Strategic Advantages of Early Access Programs (Pink Sheet-$)
  • Drug Prices After the Midterms: Five Crucial Implications of Pharmacy Benefit Design (Drug Channels)
  • US FDA Ends Nearly 2-Year Drought In Biosimilar Action Package Postings (Pink Sheet-$)
  • Mylan overhaul of West Virginia plant has a ways to go (Fierce)
  • Recro Pharma expands CDMO business in Georgia (Fierce)
  • GlaxoSmithKline, Novartis and more pharmas made big bets on digital health in Q3 2018 (mobihealthnews)
  • Eyes on neuro breakthroughs, newcomer Biomatics adds biotech vets and $300M with second fund (Endpoints)
  • Eli Lilly sweeps the rest of the BACE work out of the pipeline following their latest major setback on Alzheimer’s (Endpoints)
  • GSK’S Systemic STING Agonist Could Overcome Delivery Hurdles (BioCentury)
  • InCarda grabs a $42M round to back PoC study for their inhaled cardio drug (Endpoints)
  • Kadesh Incorporation Issues Voluntary Nationwide Recall of Puriton Eye Relief Drops Due to Non-Sterile Production Conditions (FDA)
  • The Medicines Company Reports Third-Quarter 2018 Results (Press)
  • Seres Therapeutics Reports Third Quarter Financial Results (Press)
  • TherapeuticsMD Announces Third Quarter 2018 Financial Results (Press)
  • Kala Pharmaceuticals Reports Third Quarter 2018 Financial Results (Press)
  • BioCardia Reports Third Quarter 2018 Financial Results and Business Highlights (Press)
  • Magenta Therapeutics Reports Third Quarter 2018 Financial Results (Press)
  • Deciphera Pharmaceuticals, Inc. Announces Third Quarter 2018 Financial Results (Press)
  • Ligand Reports Third Quarter 2018 Financial Results (Press)
  • Verastem Oncology Reports Third Quarter 2018 Financial Results (Press)
  • Ocular Therapeutix™ Reports Third Quarter 2018 Financial Results (Press)
  • Tedor Pharma, Inc., et al.; Withdrawal of Approval of 10 Abbreviated New Drug Applications (FDA)
  • Determination That AXIRON (Testosterone) Transdermal Metered Solution, 30 Milligrams/1.5 Milliliter Actuation, Was Not Withdrawn From Sale for Reasons of Safety or Effectiveness (FDA)
Pharmaceuticals & Biotechnology: Study Results, Filings & Designations
  • New England Journal of Medicine publishes positive detailed results from Praluent® (alirocumab) Injection cardiovascular outcomes trial (Press)
  • Urovant Sciences Completes Patient Enrollment in Phase 3 Pivotal Trial Studying Vibegron for Overactive Bladder (Press)
  • FLX Bio Highlights Phase 1 Data for FLX475 at SITC 2018 (Press)
  • Visterra Initiates Phase 1 Clinical Study of VIS649 (Press)
  • Evofem Biosciences Completes Phase 3 Clinical Trial of Amphora for Prevention of Pregnancy (Press)
  • ArQule to Present Clinical and Preclinical Data for ARQ 751 at the 30th EORTC/AACR/NCI Symposium (Press)
Medical Devices
  • FTC clears Stryker, K2M tie-up early (MassDevice)
  • 8 Things You Should Know about the EU MDRs (MDDI)
  • The Diagnostic Artificial Intelligence Speedbump Nobody’s Mentioning (Drug & Device Law)
  • May FDA Regulate Medical Devices As If They Were Drugs? (FDA Law Blog)
  • How medical devices like pacemakers and insulin pumps can be hacked (CBS)
  • Buffett-owned DaVita plunges 9% after soaring on midterm elections (CNBC)
  • Insulet inks deal with Samsung to develop smartphone-controlled Omnipod (Drug Delivery)
  • Medtronic Begins Renal Denervation Study for High Blood Pressure Patients Prescribed Anti-Hypertensive Medication (Press)
  • Mazor posts Q3 miss, wins FDA nod for Mazor X Stealth edition (MassDevice)
  • DexCom Continues to Shine Despite Growing Competition in CGM (MDDI)
  • Class 1 Device Recall Reinforced Dual Lumen Cannula (FDA)
  • VIVA 2018 Roundup: Surmodics reports positive one-year data for SurVeil drug-coated balloon (Drug Delivery)
US: Assorted & Government
  • Politics and Pandemics (NEJM)
  • Ranbaxy Abused Generic Drug Application Process, Suit Says (Law360-$)
  • Biopharma Co. Hit With Suit Over Directors' 'Excessive' Pay (Law360-$)
  • Calif. Appeals Panel Revives Suits Over Diabetes Drugs (Law360-$)
  • When Medicaid Expands, More People Vote (NYTimes)
  • 10 Health Law and Policy Takeaways from the Midterm Election (Harvard Bill of Health)
  • The costs of heroin and naloxone: a tragic snapshot of the opioid crisis (STAT)
  • Judge raises patent award against Cochlear Ltd. to $268M (MassDevice)
Upcoming Meetings & Events Europe
  • NICE appoints experienced pharma consultant as Director of NICE Scientific Advice (Pharmafile)
  • New alliance strives to advance human-based drug evaluation (PharmaTimes)
  • Hazard Alert: SQ-RX Model 1010 Pulse Generator – used with Boston Scientific S-ICDs (TGA)
  • Notice: ICH Guidance on Reporting Adverse Reactions to Marketed Health Products (Health Canada)
Regulatory Reconnaissance is our daily intelligence briefing for the regulatory affairs space, bringing you the top regulatory news stories from around the globe. Each weekday morning, we aim to bring you the latest highlights of new approvals, meetings, legal and political developments, regulations and guidance, and the latest trends with the potential to impact regulatory affairs professionals and the industry in which they work.
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